Rockeby lines up diagnostics for FDA approval
Monday, 20 September, 2004
Rockeby biomed (ASX: RBY) has lodged a 501(k) submission for regulatory approval of its systemic candidiasis diagnostic SysCan3 with the United States Food and Drug Administration.
The submission is based on data from a recent 5 centre, 200 patient clinical trial in the United States.
This data will also be used to support a second 501(k) submission for Rockeby's CanDia5 point of care diagnostic for vaginal thrush, expected later this week.
The 501(k) process -- under which the FDA determines whether the device is equivalent to devices which have already been classified -- is a much faster process than FDA approval for drugs and other pharmaceuticals and in some circumstances may take as little as 90 days from the lodgment date.
Oxytocin analogue treats chronic abdominal pain
Researchers have developed a new class of oral painkillers to suppress chronic abdominal pain,...
'Low-risk' antibiotic linked to rise of dangerous superbug
A new study has challenged the long-held belief that rifaximin — commonly prescribed to...
Robotic hand helps cultivate baby corals for reef restoration
The soft robotic hand could revolutionise the delicate, labour-intensive process of cultivating...
